Bronchiectasis With Acute ExacerbationPhase 4NCT06209047
Bronchoscopic Levofloxacin, Gentamicin, or Sham for Acute Exacerbation of Bronchiectasis
A Phase 4 study testing Local instillation of gentamicin and Budesonide, Local instillation of Levofloxacin and Budesonide and Bronchoscopic mechanical secretion suction and lavage in people with Bronchiectasis With Acute Exacerbation, run by Assiut University at 1 site in Egypt.
Trial summary
Randomized single-center trial evaluating whether bronchoscopic instillation of levofloxacin or gentamicin improves outcomes compared to a sham bronchoscopic procedure in adult ICU patients with non-cystic fibrosis bronchiectasis requiring invasive mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiectasis With Acute Exacerbation
- What is being tested?
- Local instillation of gentamicin and Budesonide, Local instillation of Levofloxacin and Budesonide and Bronchoscopic mechanical secretion suction and lavage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 315 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2023to 1 Feb 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with bronchiectasis confirmed by high-resolution CT chest(HRCT)
- patients with acute exacerbation of bronchiectasis who need antibiotic treatment at the hospital due to exacerbation
- mechanically ventilated patients in the respiratory ICU
- Age more than or equal to 18 years
Who cannot join
- patients with active pulmonary tuberculosis
- patients with allergic bronchopulmonary aspergillosis
- patients who underwent interventional bronchoscopy for hemoptysis
- age less than 18 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Assiut university hospitals
Asyut, 71515
Ali A Ali, MSc, 01064756136, aliabuzaid@aun.edu.eg
Ahmad M Shaddad, MD
About this study
Official title: A Randomized Sham-Controlled Trial of Bronchoscopic Levofloxacin and Gentamicin Versus Sham in Mechanically Ventilated Bronchiectasis: Acute and 1-Year Outcomes
Randomized single-center trial evaluating whether bronchoscopic instillation of levofloxacin or gentamicin improves outcomes compared to a sham bronchoscopic procedure in adult ICU patients with non-cystic fibrosis bronchiectasis requiring invasive mechanical ventilation. The primary outcome is a ranked composite of in-hospital mortality and time to ventilator liberation. Safety and procedural adverse events are closely monitored.
Read the detailed description
Bronchiectasis is a chronic suppurative and inflammatory lung disease of diverse etiology characterized by pathological and irreversible dilatation of the bronchial tree. The impairment of the mucociliary clearance, which results from chronic airway inflammation, may cause long-term colonization or recurrent infection of bacteria, especially Pseudomonas aeruginosa (PA), while bacterial colonization and recurrent infection can aggravate airway inflammation. Sputum retention caused by the impairment of mucociliary clearance can result in mucous plugs, which in turn contribute to airflow obstruction and dyspnea.
Clinically, the major manifestations of bronchiectasis include chronic cough with purulent sputum, dyspnea, and fatigue, which can significantly diminish patients' quality of life. The frequency of exacerbations and decline in lung function may lead to a poor prognosis and a decrease in quality of life.
The purpose of bronchiectasis management is to reduce exacerbations, prevent complications, and improve the quality of life. Long-term instillation of antibiotics and steroids can reduce the concentration of bacteria in the airways, decrease sputum production, attenuate lung function decline, and reduce acute pulmonary exacerbations without nephrotoxicity or ototoxicity. Dexamethasone is one of the most common glucocorticoids that can inhibit the expression levels of inflammatory factors in the airway and reduce the secretion of airway mucus. Topical administration could also reduce the systemic side effects.
- Conditions
- Bronchiectasis With Acute Exacerbation
- Being tested
- Local instillation of gentamicin and Budesonide, Local instillation of Levofloxacin and Budesonide, Bronchoscopic mechanical secretion suction and lavage, Sham Bronchoscopy
- Keywords
- Bronchiectasis, Bronchoscopy, Levofloxacin, Gentamicins, Steroids
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local instillation of gentamicin and BudesonideDrug
Also called Bronchoscopic instillation of gentamicin and steroids
Bronchoscopic local instillation of gentamicin and Budesonide
Local instillation of Levofloxacin and BudesonideDrug
Also called Bronchoscopic instillation of levofloxacin and steroids
Bronchoscopic local instillation of Levofloxacin and Budesonide
Bronchoscopic mechanical secretion suction and lavageProcedure or surgery
Bronchoscopic mechanical secretion suction and lavage
Sham BronchoscopyProcedure or surgery
Also called Masking intervention
Bronchoscopy for airway visualization only, no lavage or drug instillation (sham procedure).
| Study group | Role | What they receive |
|---|---|---|
| Gentamicin group | Experimental | This arm will undergo bronchoscopic airway clearance followed by local instillation of gentamicin (80 mg once) and Budesonide (0.5 mg) once. Receives: Drug: Local instillation of gentamicin and Budesonide; Procedure: Bronchoscopic mechanical secretion suction and lavage |
| Levofloxacin group | Experimental | This arm will undergo bronchoscopic airway clearance followed by bronchoscopic instillation of levofloxacin 480 mg in isotonic saline during standardized bronchoscopy. And Budesonide (0.5 mg) once. Receives: Drug: Local instillation of Levofloxacin and Budesonide; Procedure: Bronchoscopic mechanical secretion suction and lavage |
| Sham group | Sham comparator | Bronchoscopy for airway visualization only, no lavage or drug instillation (sham procedure). Receives: Procedure: Sham Bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days for weaning from mechanical ventilation
days of mechanical ventilation will be measured and compared between drug and conventional groups
Measured: one month
Secondary outcomes (7)
The amount of sputum production per day(ml/day)
The total amount of sputum per day will be measured and compared between the drug and conventional groups
Measured: one year
6-minute walking distance (meters)
The total recorded distance in 6 minutes in meters
Measured: one year
number of exacerbations (recorded number/year)
The number of reported exacerbations in one year
Measured: one year
Hospital admission
The number of reported hospital admissions in one year
Measured: one year
Quality of life assessment in bronchiectasis patients
The quality of life assessment in bronchiectasis patients using patient-reported outcome measures (Quality of Life Bronchiectasis questionnaire). It consists of 8 domains scored on a 0 - 100 scale (higher equals better QoL)
Measured: one year
Evaluation of anxiety in bronchiectasis patients using the Hamilton Anxiety rating Scale
The anxiety in bronchiectasis patients will be measured using the Hamilton Anxiety rating scale, which consists of 14 items ranging from 0 - 56 (higher equals more anxiety).
Measured: one year
Evaluation of depression in bronchiectasis patients using the Hamilton Depression Rating Scale
The depression in bronchiectasis patients will be measured using the Hamilton Depression rating scale, which consists of 17 items ranging from 0 - 52 (higher equals more depression).
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start15 Oct 2023
- Primary completion15 May 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Bronchiectasis With Acute ExacerbationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arm 1: Levofloxacin Bronchoscopic instillation of levofloxacin 500 mg in isotonic saline during standardized bronchoscopy. Arm 2: Gentamicin Bronchoscopic instillation of gentamicin 80 mg in isotonic saline during standardized bronchoscopy. Arm 3: Sham Bronchoscopy for airway visualization only, no lavage or drug instillation (sham procedure).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 315 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Abuzaid Ali, Assiut University
- Investigators
- Ali A Ali, MSc, Principal investigator, Assiut UniversityAliae A Hussien, MD, Study chair, Assiut UniversityAhmad M Shaddad, MD, Study director, Assiut UniversityMaiada K Hashem, MD, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06209047
- Sponsor's protocol ID
- AU-12578383
- Status last verified
- Jul 2025
- First submitted
- 26 Dec 2023
- Last updated
- 17 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All participant data will be recorded using a unique, study-specific Participant Identification (PID) number. This PID is not derived from any personal information and will be used for all data collection, analysis, and future data sharing. All datasets intended for sharing or publication will be thoroughly de-identified, with no direct or indirect personal identifiers included. Results from this trial will be published in two main peer-reviewed manuscripts: one reporting outcomes from the acute hospitalization phase (primary analysis), and a second reporting on long-term, 1-year follow-up outcomes. Both publications will use only de-identified PID-linked data and will cite the same ClinicalTrials.gov registration number.
Publications
Chan SC, Shum DK, Tipoe GL, Mak JC, Leung ET, Ip MS. Upregulation of ICAM-1 expression in bronchial epithelial cells by airway secretions in bronchiectasis. Respir Med. 2008 Feb;102(2):287-98. doi: 10.1016/j.rmed.2007.08.013. Epub 2007 Oct 10.
PubMed 17931847Murray MP, Govan JR, Doherty CJ, Simpson AJ, Wilkinson TS, Chalmers JD, Greening AP, Haslett C, Hill AT. A randomized controlled trial of nebulized gentamicin in non-cystic fibrosis bronchiectasis. Am J Respir Crit Care Med. 2011 Feb 15;183(4):491-9. doi: 10.1164/rccm.201005-0756OC. Epub 2010 Sep 24.
PubMed 20870753King PT, Holdsworth SR, Freezer NJ, Villanueva E, Holmes PW. Characterisation of the onset and presenting clinical features of adult bronchiectasis. Respir Med. 2006 Dec;100(12):2183-9. doi: 10.1016/j.rmed.2006.03.012. Epub 2006 May 2.
PubMed 16650970McShane PJ, Naureckas ET, Tino G, Strek ME. Non-cystic fibrosis bronchiectasis. Am J Respir Crit Care Med. 2013 Sep 15;188(6):647-56. doi: 10.1164/rccm.201303-0411CI.
PubMed 23898922Flume PA, Chalmers JD, Olivier KN. Advances in bronchiectasis: endotyping, genetics, microbiome, and disease heterogeneity. Lancet. 2018 Sep 8;392(10150):880-890. doi: 10.1016/S0140-6736(18)31767-7.
PubMed 30215383Polverino E, Goeminne PC, McDonnell MJ, Aliberti S, Marshall SE, Loebinger MR, Murris M, Canton R, Torres A, Dimakou K, De Soyza A, Hill AT, Haworth CS, Vendrell M, Ringshausen FC, Subotic D, Wilson R, Vilaro J, Stallberg B, Welte T, Rohde G, Blasi F, Elborn S, Almagro M, Timothy A, Ruddy T, Tonia T, Rigau D, Chalmers JD. European Respiratory Society guidelines for the management of adult bronchiectasis. Eur Respir J. 2017 Sep 9;50(3):1700629. doi: 10.1183/13993003.00629-2017. Print 2017 Sep.
PubMed 28889110
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Sham-Controlled Trial of Bronchoscopic Levofloxacin and Gentamicin Versus Sham in Mechanically Ventilated Bronchiectasis: Acute and 1-Year Outcomes
- ClinicalTrials.gov ID
- NCT06209047
- Acronym / sponsor ID
- AU-12578383
- Conditions
- Bronchiectasis With Acute Exacerbation
- Keywords
- Bronchiectasis, Bronchoscopy, Levofloxacin, Gentamicins, Steroids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 315 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 17 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized single-center trial evaluating whether bronchoscopic instillation of levofloxacin or gentamicin improves outcomes compared to a sham bronchoscopic procedure in adult ICU patients with non-cystic fibrosis bronchiectasis requiring invasive mechanical ventilation. The primary outcome is a ranked composite of in-hospital mortality and time to ventilator liberation. Safety and procedural adverse events are closely monitored.
Detailed description
Bronchiectasis is a chronic suppurative and inflammatory lung disease of diverse etiology characterized by pathological and irreversible dilatation of the bronchial tree. The impairment of the mucociliary clearance, which results from chronic airway inflammation, may cause long-term colonization or recurrent infection of bacteria, especially Pseudomonas aeruginosa (PA), while bacterial colonization and recurrent infection can aggravate airway inflammation. Sputum retention caused by the impairment of mucociliary clearance can result in mucous plugs, which in turn contribute to airflow obstruction and dyspnea.
Clinically, the major manifestations of bronchiectasis include chronic cough with purulent sputum, dyspnea, and fatigue, which can significantly diminish patients' quality of life. The frequency of exacerbations and decline in lung function may lead to a poor prognosis and a decrease in quality of life.
The purpose of bronchiectasis management is to reduce exacerbations, prevent complications, and improve the quality of life. Long-term instillation of antibiotics and steroids can reduce the concentration of bacteria in the airways, decrease sputum production, attenuate lung function decline, and reduce acute pulmonary exacerbations without nephrotoxicity or ototoxicity. Dexamethasone is one of the most common glucocorticoids that can inhibit the expression levels of inflammatory factors in the airway and reduce the secretion of airway mucus. Topical administration could also reduce the systemic side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Arm 1: Levofloxacin Bronchoscopic instillation of levofloxacin 500 mg in isotonic saline during standardized bronchoscopy. Arm 2: Gentamicin Bronchoscopic instillation of gentamicin 80 mg in isotonic saline during standardized bronchoscopy. Arm 3: Sham Bronchoscopy for airway visualization only, no lavage or drug instillation (sham procedure).
| Arm | Type | Receives |
|---|---|---|
| Gentamicin group | Experimental | Drug: Local instillation of gentamicin and Budesonide, Procedure: Bronchoscopic mechanical secretion suction and lavageThis arm will undergo bronchoscopic airway clearance followed by local instillation of gentamicin (80 mg once) and Budesonide (0.5 mg) once. |
| Levofloxacin group | Experimental | Drug: Local instillation of Levofloxacin and Budesonide, Procedure: Bronchoscopic mechanical secretion suction and lavageThis arm will undergo bronchoscopic airway clearance followed by bronchoscopic instillation of levofloxacin 480 mg in isotonic saline during standardized bronchoscopy. And Budesonide (0.5 mg) once. |
| Sham group | Sham comparator | Procedure: Sham BronchoscopyBronchoscopy for airway visualization only, no lavage or drug instillation (sham procedure). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with bronchiectasis confirmed by high-resolution CT chest(HRCT)
- patients with acute exacerbation of bronchiectasis who need antibiotic treatment at the hospital due to exacerbation
- mechanically ventilated patients in the respiratory ICU
- Age more than or equal to 18 years
Key exclusion criteria (4 listed)
- patients with active pulmonary tuberculosis
- patients with allergic bronchopulmonary aspergillosis
- patients who underwent interventional bronchoscopy for hemoptysis
- age less than 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Local instillation of gentamicin and BudesonideAlso: Bronchoscopic instillation of gentamicin and steroidsBronchoscopic local instillation of gentamicin and Budesonide | Drug | Gentamicin group |
| Local instillation of Levofloxacin and BudesonideAlso: Bronchoscopic instillation of levofloxacin and steroidsBronchoscopic local instillation of Levofloxacin and Budesonide | Drug | Levofloxacin group |
| Bronchoscopic mechanical secretion suction and lavageBronchoscopic mechanical secretion suction and lavage | Procedure or surgery | Gentamicin group, Levofloxacin group |
| Sham BronchoscopyAlso: Masking interventionBronchoscopy for airway visualization only, no lavage or drug instillation (sham procedure). | Procedure or surgery | Sham group |
Primary outcome
Days for weaning from mechanical ventilation
Time frame: one month
days of mechanical ventilation will be measured and compared between drug and conventional groups
7 secondary outcomes
The amount of sputum production per day(ml/day)
Time frame: one year
6-minute walking distance (meters)
Time frame: one year
number of exacerbations (recorded number/year)
Time frame: one year
Hospital admission
Time frame: one year
Quality of life assessment in bronchiectasis patients
Time frame: one year
Evaluation of anxiety in bronchiectasis patients using the Hamilton Anxiety rating Scale
Time frame: one year
Evaluation of depression in bronchiectasis patients using the Hamilton Depression Rating Scale
Time frame: one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Results publication: PubMed 17931847Chan SC, Shum DK, Tipoe GL, Mak JC, Leung ET, Ip MS. Upregulation of ICAM-1 expression in bronchial epithelial cells by airway secretions in bronchiectasis. Respir Med. 2008 Feb;102(2):287-98. doi: 10.1016/j.rmed.2007.08.013. Epub 2007 Oct 10.
- Results publication: PubMed 20870753Murray MP, Govan JR, Doherty CJ, Simpson AJ, Wilkinson TS, Chalmers JD, Greening AP, Haslett C, Hill AT. A randomized controlled trial of nebulized gentamicin in non-cystic fibrosis bronchiectasis. Am J Respir Crit Care Med. 2011 Feb 15;183(4):491-9. doi: 10.1164/rccm.201005-0756OC. Epub 2010 Sep 24.
- Results publication: PubMed 16650970King PT, Holdsworth SR, Freezer NJ, Villanueva E, Holmes PW. Characterisation of the onset and presenting clinical features of adult bronchiectasis. Respir Med. 2006 Dec;100(12):2183-9. doi: 10.1016/j.rmed.2006.03.012. Epub 2006 May 2.
- Results publication: PubMed 23898922McShane PJ, Naureckas ET, Tino G, Strek ME. Non-cystic fibrosis bronchiectasis. Am J Respir Crit Care Med. 2013 Sep 15;188(6):647-56. doi: 10.1164/rccm.201303-0411CI.
- Results publication: PubMed 30215383Flume PA, Chalmers JD, Olivier KN. Advances in bronchiectasis: endotyping, genetics, microbiome, and disease heterogeneity. Lancet. 2018 Sep 8;392(10150):880-890. doi: 10.1016/S0140-6736(18)31767-7.
- Results publication: PubMed 28889110Polverino E, Goeminne PC, McDonnell MJ, Aliberti S, Marshall SE, Loebinger MR, Murris M, Canton R, Torres A, Dimakou K, De Soyza A, Hill AT, Haworth CS, Vendrell M, Ringshausen FC, Subotic D, Wilson R, Vilaro J, Stallberg B, Welte T, Rohde G, Blasi F, Elborn S, Almagro M, Timothy A, Ruddy T, Tonia T, Rigau D, Chalmers JD. European Respiratory Society guidelines for the management of adult bronchiectasis. Eur Respir J. 2017 Sep 9;50(3):1700629. doi: 10.1183/13993003.00629-2017. Print 2017 Sep.
- Individual participant dataSharing planned: Yes. All participant data will be recorded using a unique, study-specific Participant Identification (PID) number. This PID is not derived from any personal information and will be used for all data collection, analysis, and future data sharing. All datasets intended for sharing or publication will be thoroughly de-identified, with no direct or indirect personal identifiers included. Results from this trial will be published in two main peer-reviewed manuscripts: one reporting outcomes from the acute hospitalization phase (primary analysis), and a second reporting on long-term, 1-year follow-up outcomes. Both publications will use only de-identified PID-linked data and will cite the same ClinicalTrials.gov registration number.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ali A Ali, MSc principal investigator
Assiut University
Aliae A Hussien, MD study chair
Assiut University
Ahmad M Shaddad, MD study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Local instillation of gentamicin and Budesonide, Local instillation of Levofloxacin and Budesonide and Bronchoscopic mechanical secretion suction and lavage in people with Bronchiectasis With Acute Exacerbation, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali A Ali, MSc (+2001064756136, aliabuzaid@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days for weaning from mechanical ventilation (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06209047, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.